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CPC 推出全新 MicroCNX 連接器，首次用于小批量生物制藥加工
發(fā)布時(shí)間：2021 年 9 月 1 日

小管徑焊接的唯一替代方案

丹尼森市，伊利諾伊州， 2021年9月1日/新華美通/ - CPC（冷產(chǎn)品公司）的一部分，多佛（紐約證券交易所代碼：DOV）和廣泛的單次使用的連接器制造商，今天宣布推出一個(gè)新的超- 緊湊型無菌連接器為生物制藥制造商提供了一種急需的替代管焊接的小體積封閉無菌工藝。MicroCNX 系列連接器是業(yè)界首款無菌連接器，旨在提供一種簡單、高效的方法來連接小型組件中的管道。

“MicroCNX 連接器是一系列生物加工、細(xì)胞治療和基因治療工作流程的關(guān)鍵選擇，” CPC 生物制藥業(yè)務(wù)高級(jí)產(chǎn)品經(jīng)理Troy Ostreng說。“到目前為止，繁瑣的管道焊接一直是對非常小口徑的管道進(jìn)行無菌封閉連接的 一方法。MicroCNX 連接器代表了該行業(yè)的一項(xiàng)巨大創(chuàng)新。”

MicroCNX 連接器專為涉及廣泛使用的 1/16" (1.6mm)、3/32" (2.4mm) 和 1/8" (3.2mm) 管的小體積過程而設(shè)計(jì)。這些包括采樣、種子序列擴(kuò)展和早期涉及搖瓶和搖床的細(xì)胞培養(yǎng)過程。

“MicroCNX 系列旨在幫助制造商提高效率并減少創(chuàng)建封閉系統(tǒng)的時(shí)間和總成本，從而提供可靠、可重復(fù)的結(jié)果，”O(jiān)streng 說。

測試表明，使用新連接器進(jìn)行無菌連接的速度比使用管焊機(jī)的操作員快四倍。1意思是，在創(chuàng)建一個(gè)焊縫所需的時(shí)間內(nèi)，多可以完成四個(gè) MicroCNX 連接。將這些數(shù)字在一年中相乘，運(yùn)營效率就很明顯了。

使用 MicroCNX 連接器的簡單三步過程需要少的培訓(xùn)。用戶只需“捏-按-拉”：1）捏可取下保護(hù)蓋；2) 將連接器的兩半卡在一起；并且，3) 拉出保護(hù)膜，以便開始流動(dòng)。相比之下，管焊接涉及十幾個(gè)或更多步驟，操作員面臨的挑戰(zhàn)包括將管焊機(jī)操縱到位、處理設(shè)備維護(hù)以及需要精確的技術(shù)來創(chuàng)建成功的焊接。使用 MicroCNX 解決方案，不存在因焊接設(shè)備停機(jī)而導(dǎo)致焊接錯(cuò)誤、焊機(jī)故障或生產(chǎn)延遲的風(fēng)險(xiǎn)。

使用無菌連接器無需購買、校準(zhǔn)、驗(yàn)證和維護(hù)每臺(tái)成本超過15,000 美元的管焊機(jī)。制造商通常需要多名焊工，這會(huì)占用潔凈室的寶貴空間。

“驗(yàn)證新空間既昂貴又耗時(shí)，”O(jiān)streng 指出�！癕icroCNX 連接器可以幫助生物制藥、細(xì)胞和基因治療制造商充分利用他們現(xiàn)有的潔凈室空間�！�

為了確保流路暢通，管子焊接需要操作員在被焊縫卷曲后手動(dòng)恢復(fù)管子的形狀。相比之下，MicroCNX 連接器有助于為每個(gè)連接提供一致的流動(dòng)路徑。由于 MicroCNX 連接器可以集成到預(yù)制的管道組件中，操作員知道在哪里進(jìn)行連接——他們無需猜測，這支持當(dāng)前的良好制造規(guī)范 (cGMP)。新連接器的尺寸、重量和幾何形狀也非常符合用于細(xì)胞擴(kuò)展等過程的緊湊型自動(dòng)化設(shè)備的趨勢。

有關(guān) MicroCNX 系列連接器以及管焊接和無菌連接器比較的更多信息，請?jiān)L問http://jygdb91.com/MicroCNX_Connectors.htm

檔案資料。

關(guān)于 CPC：

CPC（Colder Products Company）是一次性連接技術(shù)的全球領(lǐng)導(dǎo)者，為生物制藥制造提供各種連接器。創(chuàng)新、靈活的設(shè)計(jì)可輕松組合多個(gè)組件和系統(tǒng)，包括工藝容器、管道歧管、傳輸線、生物反應(yīng)器和其他生物工藝設(shè)備。堅(jiān)固的一次性連接器可保持介質(zhì)的無菌性和完整性，同時(shí)提高產(chǎn)量、縮短上市時(shí)間并降低成本。該公司著名的 AseptiQuik 連接器即使在非無菌環(huán)境中也能提供快速簡便的無菌連接。在cpcworldwide.com/bio 上了解有關(guān)我們整個(gè)產(chǎn)品組合的更多信息。與 Dover Corporation 旗下的運(yùn)營公司 CPC 充滿信心地聯(lián)系。

關(guān)于 Dover：

Dover 是一家多元化的全球制造商和解決方案提供商，年收入約為70 億美元。我們通過五個(gè)運(yùn)營部門提供創(chuàng)新設(shè)備和組件、消耗品、售后零件、軟件和數(shù)字解決方案以及支持服務(wù)：工程產(chǎn)品、加油解決方案、成像和識(shí)別、泵和過程解決方案以及制冷和食品設(shè)備。Dover 將全球規(guī)模與運(yùn)營敏捷性相結(jié)合，引領(lǐng)我們服務(wù)的市場。我們擁有 24,000 多名員工的團(tuán)隊(duì)以擁有超過 65 年的創(chuàng)業(yè)方法而獲得認(rèn)可，采用主人翁心態(tài)，與客戶合作重新定義可能。總部位于伊利諾伊州唐納斯格羅夫，多佛在紐約證券交易所的交易名稱為“DOV”。

CPC Launches New MicroCNX Connectors, a First for Small-Volume Biopharma Processing
Published: Sep 01, 2021

Only alternative to tube welding at small tubing sizes

DOWNERS GROVE, Ill., Sept. 1, 2021 /PRNewswire/ – CPC (Colder Products Company), part of Dover (NYSE: DOV) and maker of a broad range of single-use connectors, today announced the launch of a new ultra-compact sterile connector providing biopharmaceutical manufacturers a much-needed alternative to tube welding for their small-volume closed aseptic processes. MicroCNX Series Connectors are the industry's first aseptic connectors designed to provide a simple, efficient method of connecting tubing in small-format assemblies.

"MicroCNX connectors are a critically important option for a range of bioprocessing, cell therapy and gene therapy workflows," said Troy Ostreng, Senior Product Manager for CPC's biopharmaceutical business. "Until now, cumbersome tube welding has been the only way to make sterile closed connections of very small-bore tubing. The MicroCNX connector represents a huge innovation for the industry."

MicroCNX connectors are designed specifically for small-volume processes involving widely used 1/16" (1.6mm), 3/32" (2.4mm) and 1/8" (3.2mm) tubing. These include sampling, seed train expansion and early cell culture processes involving shaker flasks and rocker tables.

"The MicroCNX series was designed to help manufacturers improve efficiencies and reduce time and total cost in creating closed systems that deliver reliable, reproducible results," said Ostreng.

Testing indicates that making a sterile connection with the new connector is up to four times faster than an operator using a tube welder.1 Meaning, in the time required to create one weld, up to four MicroCNX connections could be completed. Multiply those numbers over the course of a year, and the operational efficiencies are clear.

The easy, three-step process for using MicroCNX connectors requires minimal training. Users simply "Pinch-Click-Pull": 1) pinch to remove the protective cover; 2) click together the connector halves; and, 3) pull out the protective membranes so flow can start. In comparison, tube welding involves a dozen or more steps, with operator challenges including maneuvering the tube welder into position, dealing with equipment maintenance, and requiring precise technique to create a successful weld. With MicroCNX solutions, there is no risk of faulty welds, welder breakdowns, or production delays due to weld equipment downtime.

Use of aseptic connectors eliminates the need to purchase, calibrate, validate and maintain tube welders that can cost more than $15,000 each. Manufacturers often need multiple welders, which take up valuable space in a cleanroom.

"It's expensive and time-consuming to validate new space," Ostreng noted. "MicroCNX connectors can help biopharmaceutical and cell and gene therapy manufacturers make the most of their existing cleanroom space."

In order to ensure a clear flow path, tube welding requires operators to manually restore the tubing's shape after being crimped by a weld. In contrast, MicroCNX connectors help deliver a consistent flow path with every connection. Because MicroCNX connectors can be incorporated into pre-made tubing assemblies, operators know where to make connections—there's no guesswork on their part, which supports current good manufacturing practices (cGMP). The size, weight and geometry of the new connector also fit well with the trend toward compact automated equipment for use in processes like cell expansion.

For more information about MicroCNX Series Connectors and how tube welding and aseptic connectors compare, visit endoftheweld.com.

1. Data on file.

About CPC:
CPC (Colder Products Company) is a global leader in single-use connection technology, offering a wide variety of connectors for biopharmaceutical manufacturing. Innovative, flexible designs easily combine multiple components and systems including process containers, tubing manifolds, transfer lines, bioreactors and other bioprocess equipment. Robust single-use connectors maintain media sterility and integrity while improving production yields, decreasing time to market and reducing costs. The company's well-known AseptiQuik connectors provide quick and easy sterile connections even in non-sterile environments. Learn more about our entire portfolio at cpcworldwide.com/bio. Connect with confidence with CPC, an operating company within Dover Corporation.

About Dover:
Dover is a diversified global manufacturer and solutions provider with annual revenue of approximately $7 billion. We deliver innovative equipment and components, consumable supplies, aftermarket parts, software and digital solutions, and support services through five operating segments: Engineered Products, Fueling Solutions, Imaging & Identification, Pumps & Process Solutions and Refrigeration & Food Equipment. Dover combines global scale with operational agility to lead the markets we serve. Recognized for our entrepreneurial approach for over 65 years, our team of over 24,000 employees takes an ownership mindset, collaborating with customers to redefine what's possible. Headquartered in Downers Grove, Illinois, Dover trades on the New York Stock Exchange under "DOV."

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